EP0820301A4 - Tissue graft and method for urinary bladder reconstruction - Google Patents
Tissue graft and method for urinary bladder reconstructionInfo
- Publication number
- EP0820301A4 EP0820301A4 EP96911561A EP96911561A EP0820301A4 EP 0820301 A4 EP0820301 A4 EP 0820301A4 EP 96911561 A EP96911561 A EP 96911561A EP 96911561 A EP96911561 A EP 96911561A EP 0820301 A4 EP0820301 A4 EP 0820301A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- tissue
- submucosal
- bladder
- graft
- submucosal tissue
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
- A61L27/3629—Intestinal tissue, e.g. small intestinal submucosa
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/37—Digestive system
- A61K35/38—Stomach; Intestine; Goblet cells; Oral mucosa; Saliva
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
- A61L27/3679—Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/22—Materials or treatment for tissue regeneration for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
Definitions
- Intestinal submucosal tissue has undergone extensive im unologic testing in over 600 cross-species implants and has never been shown to elucidate a rejection reaction. Furthermore, it is known that intestinal submucosa can be fluidized by comminuting and/or protease digestion, without loss of its apparent biotropic properties, for use in less invasive methods of administration (e.g., injection or topical) to host tissues in need of repair. See U.S. Patent No. 5,275,826.
- submucosal tissue is used as a tissue graft for replacing/reconstructing damaged or diseased urothelial tissue of the urinary tract.
- Urothelial tissue is defined herein as including the cells and tissues of the ureter, urethra and renal collection system.
- the submucosal graft constructs promote the growth of endogenous urothelial tissues upon implantation into a host organism. These graft constructs can be used to replace large sections of the ureter, uretha and urinary bladder.
- the tissue graft construct can be formed in the shape of a pouch to assist in the replacement of large portions (i.e., greater than 20%) of the urinary bladder.
- the construct can be formed by surgical construction from one or more submucosal strips or by a compression-forming procedure such as that described above.
- the tissue graft construct can be manipulated to form ports in the tissue graft for surgical attachment and fluid communication with the ureters and the urethra.
- Canine intestinal submucosal tissue was used in the pig as a xenogeneic material.
- the intestinal submucosal tissue for the graft was used within 1 to 5 days of collection.
- the intestinal submucosal tissue for injection was prepared by mechanical emulsification of the tissue to enable injection of the suspension through an 18- gauge needle.
- Four female pigs were randomly selected for either bladder wall, bladder neck, or periureteral intestinal submucosal tissue injection.
- Fluidized intestinal submucosal tissue (10-20 mL) was injection through an 18-gauge needle into submucosal or subserosal sites to create a discrete nodule.
- the volume of the urinary bladder prior to surgery was approximately 51 mis and at the time of sacrifice the urinary bladder volume was approximately 55 mis.
- the size of the urinary bladder was retained with the use of the submucosal tissue graft material and there was no evidence of shrinkage as would be expected in "scarring".
Abstract
Description
Claims
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US41851695A | 1995-04-07 | 1995-04-07 | |
US418516 | 1995-04-07 | ||
PCT/US1996/004590 WO1996031232A1 (en) | 1995-04-07 | 1996-04-03 | Tissue graft and method for urinary bladder reconstruction |
Publications (3)
Publication Number | Publication Date |
---|---|
EP0820301A1 EP0820301A1 (en) | 1998-01-28 |
EP0820301A4 true EP0820301A4 (en) | 1998-07-08 |
EP0820301B1 EP0820301B1 (en) | 2002-07-24 |
Family
ID=23658445
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP96911561A Expired - Lifetime EP0820301B1 (en) | 1995-04-07 | 1996-04-03 | Tissue graft for urinary bladder reconstruction |
Country Status (7)
Country | Link |
---|---|
US (2) | US5645860A (en) |
EP (1) | EP0820301B1 (en) |
JP (2) | JPH11508151A (en) |
AU (1) | AU692094B2 (en) |
CA (1) | CA2214407C (en) |
DE (1) | DE69622548T2 (en) |
WO (1) | WO1996031232A1 (en) |
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- 1996-04-03 CA CA002214407A patent/CA2214407C/en not_active Expired - Lifetime
- 1996-04-03 AU AU54413/96A patent/AU692094B2/en not_active Ceased
- 1996-04-03 DE DE69622548T patent/DE69622548T2/en not_active Expired - Lifetime
- 1996-04-03 EP EP96911561A patent/EP0820301B1/en not_active Expired - Lifetime
- 1996-04-16 US US08/632,756 patent/US5645860A/en not_active Expired - Lifetime
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Also Published As
Publication number | Publication date |
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EP0820301B1 (en) | 2002-07-24 |
DE69622548D1 (en) | 2002-08-29 |
JP2005349213A (en) | 2005-12-22 |
WO1996031232A1 (en) | 1996-10-10 |
US5645860A (en) | 1997-07-08 |
AU5441396A (en) | 1996-10-23 |
EP0820301A1 (en) | 1998-01-28 |
CA2214407A1 (en) | 1996-10-10 |
DE69622548T2 (en) | 2003-09-18 |
AU692094B2 (en) | 1998-05-28 |
US5762966A (en) | 1998-06-09 |
CA2214407C (en) | 2008-06-17 |
JPH11508151A (en) | 1999-07-21 |
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